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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 1095817 | Other Identifier | University of Missouri |
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Study personnel left institution before study completion
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The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.
Dry eye disease affects millions of people world-wide, and presents with symptoms of blurred vision, discharge from the eyes, eye discomfort, burning, redness, sandy and gritty feeling in the eyes, and sensitivity to light. Topical eye drops for eye lubrication (i.e., artificial tear solutions) and controlling ocular inflammation through the use of topical immunomodulatory agents (i.e., cyclosporine [Restasis]) have been shown to be effective for treating dry eye syndrome, but are not curative. Recently, we have evaluated a few patients who had discontinued using Restasis as they had obtained better relief of their dry eye symptoms with a homeopathic therapy.
Potential participants will undergo an eye examination consisting of medical history and physical examination (i.e., visual acuity, pupillary exam, examination of the lids, slit-lamp examination of the conjunctiva, cornea, anterior chamber, iris, and lens, and funduscopic examination). Participants qualifying for the study will then stop all eye medications and will use a common artificial tear solution for 2 weeks prior to the baseline examination. We will evaluate 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film to break-up; 2) staining of the cornea by fluorescein stain; 3) measurement of tear production over 5 minutes by Schirmer's test; and 4) the Ocular Surface Disease Index (OSDI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin solution (Restasis) . |
|
| Control | Placebo Comparator | Subjects will receive placebo in combination with cyclosporin solution (Restasis) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euphrasia-based homeopathic therapy | Drug | ophthalmic solution; 1 drop both eyes twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) | Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability. | Start of treatment, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tear Film Breakup Time | Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease. | Baseline, 6 weeks |
| Change in Fluorescein Staining Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Ocular Discomfort | This will be calculated using a composite score of the primary and secondary outcome measures. | Baseline, 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lenworth N Johnson, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia, Mason Eye Institute | Columbia | Missouri | 65212 | United States |
Participants will stop all common artificial tear use for 2 weeks prior to baseline examination and randomization.
Study was conducted Dec 2007 to Sept 2008. Participants were evaluated in the Mason Eye Institute and underwent 4 measures of dry eyes at baseline and after 6 weeks of therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). |
| FG001 | Control | Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 Arm Study - Description Below | Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Ocular Surface Disease Index (OSDI) | Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability. | Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution. | Posted | Start of treatment, 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Arm Study - Description Below | Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). |
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Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lenworth Johnson, MD | University of Missouri | 573-882-8473 | JohnsonLN@health.missouri.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Cyclosporin solution | Drug | Cyclosporin solution; 1 drop both eyes twice daily |
|
|
Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.
| Baseline, 6 weeks |
| Change in Schirmer Tear Test With Anesthesia Result | Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease. | Baseline, 6 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Control |
cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI). |
|
| Secondary | Change in Tear Film Breakup Time | Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease. | Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution. | Posted | Baseline, 6 weeks |
|
|
| Secondary | Change in Fluorescein Staining Scale | Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score. | Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution. | Posted | Baseline, 6 weeks |
|
|
| Secondary | Change in Schirmer Tear Test With Anesthesia Result | Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease. | Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution. | Posted | Baseline, 6 weeks |
|
|
| Other Pre-specified | Change in Severity of Ocular Discomfort | This will be calculated using a composite score of the primary and secondary outcome measures. | Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution. | Posted | Baseline, 6 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
This study had no external sponsors. It was supported by the University of Missouri, my employer. The University of Missouri can review the data at anytime.
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |